Kornimate/medical-research-clean huggingface dataset:
study of recombinant human n-acetylgalactosamine 4-sulfatase (rhasb) in patients with mps vi

Conditions: Mucopolysaccharidosis VI

Summary: the purpose of the study is to evaluate the ability of rhasb versus placebo to enhance endurance in patients with mucopolysaccharidosis vi (mps vi), as evidenced by an increase in the number of meters walked in the 12 minute walk test at week 24 compared with baseline.


Eligibility criteria:
inclusion criteria * patient consent * patient must be seven years of age or older * patient must have documented biochemical or genetic proof of mps vi * the patient must be able to walk independently at least 5 meters and no more than 270 meters in the first 6 minutes, or no more then 400 meters total in 12 minutes, in the screening 12-minute walk test * if female of childbearing potential, patient must have a negative pregnancy test exclusion criteria * patient is under consideration for or has undergone a successful bone marrow transplant (bmt) * patient refuses or is unable to complete all screening evaluations * pregnant or lactating patient * patient has received an investigational drug within 30 days prior to study enrollment * patient has been previously treated with rhasb * patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance * the patient has clinically significant spinal cord compression * the patient has known hypersensitivity to rhasb or to components of the active or placebo test solutions
alternative protein short chronic study

Conditions: Healthy

Summary: the world's population needs adequate food supply to sustain food security. the availability of sufficient dietary protein is undeniably a source of concern for human health. this study aimed to assess the satiety and potential health benefits of two types of vegetarian diets when the meat was replaced with buckwheat and respectively fava bean for one-week in the diet of healthy volunteers.

the world health organisation (who) recommends increasing the intake of fruits and vegetables, legumes, whole grains and nuts to prevent obesity. in western countries, there is a greater understanding of the health benefits of pulse grains. consumption of whole grain cereals and grain pulses has been shown to protect against a variety of inflammation-related chronic diseases. grain cereals, pulses and pseudo cereals are also good dietary protein sources. this study aimed to assess the suitability of buckwheat and fava bean to replace meat for one week in terms of delivering adequate nutrient intake, satisfying hunger and delivering potential health benefits. the composition of human microbial metabolites and the bacterial composition after consumption of the intervention diets by healthy volunteers for one week were also assessed. this study offers data to support the potential of plants as alternative sources of dietary nutrients.

Eligibility criteria:
inclusion criteria: * healthy males and females, * non-vegetarian, * non-smokers, * age 18-65 * with bmi 18-35 kg/m. exclusion criteria: * vegetarian, * smoker, * having known allergies, * using prescription drugs. * diabetes, * gastrointestinal disorders, * kidney disease, * hepatic disease, * favism, * alcohol or * substance abuse
interest of a systematic assessment of the treatment of luts in the management of bph

Conditions: Benign Prostatic Hyperplasia

Summary: the high level of unsatisfactory outcome observed in patients treated for luts associated with bph with respect to the different existing therapeutic options strongly emphasizes the need for treatment optimisation in daily practice by a careful luts monitoring and treatment adjustment when needed. the poorer outcome observed in patients for whom treatment has been initiated recently suggests that the duration of the disease itself may influence the patient satisfaction.to achieve this goal, we propose to systematically assess luts associated with bph in patients treated for at least 6 months and to assess whether an alpha-blocker therapy initiation/modification may improve the outcome in case of persisting symptoms. we also investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.


Eligibility criteria:
inclusion criteria: patients aged 60 years or more suffering from luts/bph and medically treated for at least 6 months. exclusion criteria: * patients with prostate cancer * patients requiring surgical treatment * the absence of lower urinary tract symptoms * treatment initiation for less than 6 months * cognitive disorders or other pathologies leading to the inability to give its consent to the collection of data. * refusal to participate.
a study of tq-b3525 in subjects with relapse/refractory diffuse large b-cell lymphoma （dlbcl）

Conditions: Diffuse Large B-cell Lymphoma

Summary: this is a study to evaluate the efficacy and safety of tq-b3525 in subjects with relapse/refactory diffuse large b-cell lymphoma who have received at least 2 lines of therapeutic schedules including rituximab. tq-b3525 tablet administered 20mg orally, once daily in 28-day cycle.


Eligibility criteria:
inclusion criteria: * 1.understood and signed an informed consent form; 2. 18 years and older, eastern cooperative oncology group(ecog) performance status score of 0 to 2, life expectancy ≥ 3 months; 3. relapsed/refractory diffuse large b-cell lymphoma （dlbcl); 4. has received at least two lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment, either of the treatment should conclude rituximab; 5. has at least one measurable lesion; 6. adequate organ system function; 7. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. exclusion criteria: * 1. dlbcl transformed from previously diagnosed indolent lymphoma; 2. has central nervous system violation; 3. has received other pi3k inhibitors or car-t treatments; 4. has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. has type i diabetes or uncontrolled type ii diabetes; 6.has history of interstitial lung disease; 7. has a history of immunodeficiency diseases; 8. has multiple factors affecting oral medication; 9.has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. has received systemic steroid treatment within 7 days before the first administration; 11. has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 12. has active infections within 4 weeks before the first administration; 13. has received surgery, or unhealed wounds within 4 weeks before the first administration; 14. has a history of autologous hematopoietic stem cell transplant within 3 months; 15. has a history of allogeneic hematopoietic stem cell transplant; 16. grade ii or higher cardiovascular disease within 6 months before the first administration; 17. qtcf \> 480ms, lvef \ 1g within 7 days; 19. has active hepatitis b or c; 20. has psychotropic substances abuse or a mental disorder; 21. has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
corevalve advance-ii study: prospective international post-market study

Conditions: Aortic Valve Stenosis; Valvular Heart Disease

Summary: the corevalve advance-ii study is a best practices investigation of patients implanted with the medtronic corevalve bioprosthesis.

the purpose of the study was to investigate the rate of conduction disturbances after trans-catheter aortic valve implantation of the medtronic corevalve device, aiming to characterize best practices. the investigators did not assign study specific interventions to the subjects in the study.

Eligibility criteria:
inclusion criteria: * fulfilling the criteria of labeling indications of the corevalve system; * patient is above the minimum age as required by local regulations to be participating in a clinical trial regardless of gender and race; * provided signed informed consent or data release form. exclusion criteria: * patients with a device regulating the heart rhythm by pacing (e.g. pacemaker, resynchronization device, implanted defibrillator); * patients with a pre-existing class i or class ii indication for new pacemaker implantation according to the 2007 esc guidelines; * persistent or permanent atrial fibrillation (except paroxysmal af); * participation in another drug or device study that would jeopardize the appropriate analysis of endpoints of this study. * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * pregnancy

Keywords: aortic valve stenosis valvular heart disease transcatheter aortic valve implantation
early feasibility study for the foldax tria mitral heart valve replacement

Conditions: Mitral Valve Disease; Mitral Valve Stenosis; Mitral Valve Failure

Summary: the purpose of this study is to conduct the initial clinical investigation of the foldax polymer mitral valve to collect evidence on the device's safety and performance. the study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

the foldax polymer mitral valve is indicated as a replacement for a diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. this is a first in human study conducted under us fda's early feasibility investigational device exemption and will enroll up to 15 patients. these patients will be followed up to 5 years after implantation.

Eligibility criteria:
inclusion criteria: * is 18 years or older * is a candidate for mitral valve replacement with cardiopulmonary bypass * is a candidate for mitral valve replacement due to: * moderate to severe mitral valve stenosis, * moderate to severe mitral valve regurgitation, or * moderate to severe mixed mitral stenosis/regurgitation * able to withstand short term anticoagulation * willing and able to comply with protocol requirements exclusion criteria: * prior mitral valve surgery for valve replacement or valve repair (this does not include percutaneous interventions i.e. mitraclip, chordal replacement) * requires emergency surgery * requires other planned surgery within 12 months of valve replacement * active endocarditis or active myocarditis * acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment * non-cardiac illness resulting in a life expectancy of less than 12 months * enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies) * myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment * aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications * renal or hepatic failure * hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dl, platelet count of \<100,000 cells/µl, or wbc \<4,000 cells/µl; coagulation profile must not be outside of normal limits * patients who are prisoners or mentally ill * patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating * has a positive test result for covid-19 virus (baseline or preoperative) * patients who have withdrawn after implantation may not re-enter * intraoperatively it is determined that the patient anatomy is not compatible with the device.
effects of modulators of gluconeogenesis, glycogenolysis and glucokinase activity

Conditions: Type 2 Diabetes

Summary: it has been shown that individuals with type 2 diabetes have higher blood sugar throughout the night than individuals without type 2 diabetes. however, it is still unknown if this rise in blood sugar can be controlled using medications. this study will examine the effects of three different diabetes treatments to determine if they improve night time blood sugars. participants will be randomly assigned for 8 weeks to one of the following three groups: group 1: insulin. participants will be instructed on self-injecting insulin glargine once-daily in the morning. the dose will be increased by the study team to avoid episodes of low blood sugar and to maintain fasting blood sugar concentrations between 70 to 180 mg/dl. group 2: metformin. participants will start the drug (500 mg twice daily) with meals. after 72 hours and in the absence of side effects, they will increase the dose to 500 mg with breakfast and 1,000 mg with supper. after a further 72 hours and in the absence of side effects, they will increase the dose to 1,000 mg twice daily with meals and continue until the end of the trial. the dose will be adjusted by the study team to maintain fasting blood sugar concentrations between 70 to 180 mg/dl. group 3: dorzagliatin. this medication dose will be 75 mg twice daily. the investigators anticipate fasting glucose concentrations will be between 70 to 180 mg/dl since the dose of this medication cannot be titrated.


Eligibility criteria:
inclusion criteria: * bmi:25-40 kg/m2. * hba1c ≤ 9% on lifestyle therapy with or without monotherapy with metformin or sulphonylureas (su); or combination therapies (metformin and su, dppiv inhibitors, only short acting glp-1 analogues exenatide (byeta) and liraglutide (victoza). exclusion criteria: * insulin therapy * sglt2 inhibitors * long acting glp-1 analogues * tzds * medications affecting gi motility (e.g., erythromycin, pramlintide). * medications that may affect glucose metabolism such as corticosteroids, tricyclic-antidepressants, benzodiazepines, opiates, barbiturates, and anticoagulants. * unstable diabetic retinopathy, microalbuminuria, macrovascular disease. * upper gi disorder/surgery, debilitating chronic disease, anemia, and symptoms of undiagnosed illnesses. * history of alcoholism or substance abuse. * pregnancy or breast feeding, or other comorbidities precluding participation.
burs versus curettes in root planing.

Conditions: Chronic Periodontitis

Summary: this study compares the efficacy of diamond burs and gracey curettes in non-surgical periodontal treatment of chronic periodontitis by clinical, microbiological, biochemical parameters and scanning electron microscopic investigations on root surfaces. two quadrants of each of the 12 patients were treated with diamond burs whereas other 2 quadrants were treated with gracey curettes. also 21 hopeless teeth received root planing either with diamond burs or curettes or no treatment at all and were then extracted for microscopic evaluations.

gracey curettes are the most widely used instruments for root planing and regarded as the gold standard, but their usage is technic sensitive and time consuming for the clinician and efficacy reduces in deep pockets, root irregularities, and furcations. alternative sonic, ultrasonic and rotary instruments have been investigated for potential benefits in improving mechanical access. sonic and ultrasonic instruments are used for scaling, but they cannot provide smooth root surfaces. intensiv perio set is a rotating diamond bur system developed for odontoplasty, scaling and root planing. it is used only in right angle hand piece, at rotation speeds of 6000 rpm, with reduced pressure application. these burs have two different head types for morphologically different areas; flame or tapered, three different grains; 75, 40, or 15 μm, with either a short or long neck for each unit. burs with 75 μm grain are used only in odontoplasty, whereas, 40 and 15 μm burs are used for scaling and root planing.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of generalized chronic periodontitis (armitage 1999) * presence of at least 3 teeth (1 molar, 2 non-molar teeth) with probing depth ≥ 5 mm in each quadrant exclusion criteria: * presence of any known systemic disease or using medications that affect periodontal tissues * antibiotic treatment and/or periodontal treatment within the past 6 months * tobacco usage during the last 12 months * being pregnant or in the lactation period

Keywords: non-surgical periodontal debridement root planing/instrumentation cytokine(s) dental plaque microscopy, electron, scanning
scout reflector for tagging lymph nodes for targeted removal in patients with breast cancer

Conditions: Positive Axillary Lymph Node; Stage 0 Breast Cancer AJCC v6 and v7; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7

Summary: this pilot clinical trial will evaluate whether the scout reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of surgery. the scout localization system with the savi reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.

primary objectives: i. percentage of patients with successful retrieval of the reflector confirmed by specimen radiography. ii. percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology. secondary objectives: i. total number of lymph nodes removed. ii. percentage of patients in which clipped node was a sentinel node. iii. percentage of patients with nodal pathologic complete response (pcr). iv. residual cancer burden (rcb) score for patients with residual nodal disease. v. percentage of patients requiring axillary dissection. vi. days prior to surgery of reflector insertion. outline: patients undergo image-guided placement of the scout reflector prior to course 2 of standard of care neoadjuvant chemotherapy. patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion.

Eligibility criteria:
inclusion criteria: * able to give written informed consent to participate in the study * patients with a breast cancer diagnosis of any subtype and a biopsy-proven positive axillary lymph node who will be treated first with chemotherapy * enlarged lymph node and/or clip targetable with image guidance * patients who are eligible for surgical resection of the primary breast cancer and targeted dissection of the axilla exclusion criteria: * more than 3 positive axillary nodes on imaging or matted nodes on clinical exam * stage iv breast cancer * pregnant or lactating females * patients with inflammatory breast cancer * patients with allergies to isosulfan blue or technetium, which would preclude sentinel node mapping * patients who have had previous axillary surgery, including sentinel lymph node biopsy
effect of oral ketone and sodium bicarbonate administration during endurance exercise in hypoxia

Conditions: Exercise; Hypoxia

Summary: this study is investigating the effects of oral ketone and sodium bicarbonate administration on physiological and metabolic parameters during cycling endurance exercise in hypoxia. ketone body supplementation is commonly used among elite endurance athletes that also compete in the hypoxia (at altitude). to-date effects of ketones have only been investigated in normoxia and the data in hypoxia is lacking. hence, we want to investigate the effect of oral ketone ester intake with and without additional sodium bicarbonate (nahco3) ingestion on i) blood-acid base balance and ii) exercise performance during prolonged exercise under hypoxic conditions. information obtained via this study should provide valuable information with regard to optimisation of exercise training and athletic performance, and more importantly, provide pioneering insight on the metabolic and physiological responses to ketosis under hypoxic conditions.


Eligibility criteria:
inclusion criteria: * males between 18 and 35 years old * recreational or competitive cyclist performing regularly cycling training sessions of at least 4 hours, with an average training volume of more than 6 hours per week * good health status confirmed by a medical screening * vo2max higher than 55 ml.min-1.kg-1 * body mass index (bmi) between 18 and 25 exclusion criteria: * any kind of injury/pathology that is a contra-indication to perform high-intensity exercise * intake of any medication or nutritional supplement that is known to affect exercise performance * intake of analgesics, anti-inflammatory agents, or supplementary anti-oxidants, from 2 weeks prior to the start of the study. * blood donation within 3 months prior to the start of the study * smoking * more than 3 alcoholic beverages per day, including a maximum of one glass of wine per day * involvement in elite athletic training at a semi-professional or professional level * current participation in another research trial * any other argument to believe that the subject is unlikely to successfully complete the full study protocol

Keywords: exercise hypoxia ketone
a study to evaluate the safety of escalating doses of ocrelizumab in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a randomized, placebo-controlled, multicenter, blinded phase i/ii, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with mtx in subjects with moderate to severe ra


Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent and to comply with the requirements of the protocol * diagnosis of ra for at least 6 months according to the revised 1987 acr criteria for the classification of ra * positive serum rf * current treatment for ra on an outpatient basis * contact your local site that is listed for more inclusion criteria exclusion criteria: * bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization * rheumatic autoimmune disease other than ra or significant systemic involvement secondary to ra (e.g., vasculitis, pulmonary fibrosis, or felty�s syndrome) * functional class iv as defined by the acr classification of functional status in ra * history of or current inflammatory joint disease other than ra (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome) * contact your local site that is listed for more exclusion criteria

Keywords: moderate to severe rheumatoid arthritis